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Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially… Read more
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Chapter 1: Quality-by-design in pharmaceutical development
1.1 Introduction
1.2 ICH Q8 guideline
1.3 Regulatory and industry views on QbD
1.4 Scientifically based QbD - examples of application
1.5 Conclusion
Chapter 2: Computer-aided formulation development
2.1 Introduction
2.2 Application of computer-aided techniques in development of pharmaceutical emulsions
2.3 Application of computer-aided techniques in development of microemulsion drug carriers
2.4 Conclusion
Chapter 3: Experimental design application and interpretation in pharmaceutical technology
3.1 Introduction
3.2 Theory
3.3 Examples
Chapter 4: Chemometric methods application in pharmaceutical products and processes analysis and control
4.1 Introduction
4.2 Theory
4.3 Examples
Chapter 5: Neural computing in pharmaceutical products and process development
5.1 Artificial neural networks
5.2 Fuzzy logic
5.3 Decision trees
5.4 Evolutionary computing and genetic algorithms
5.4.1 Theory
5.5 Self-organizing maps
5.6 Conclusion
Chapter 6: Computer-aided biopharmaceutical characterization: gastrointestinal absorption simulation
6.1 Introduction
6.2 Theoretical background
6.3 Model construction
6.4 Parameter sensitivity analysis
6.5 Virtual trial
6.6 Fed vs. fasted state
6.7 In vitro dissolution and in vitro-in vivo correlation
6.8 Biowaiver considerations
6.9 Conclusions
Chapter 7: Computational fluid dynamics: applications in pharmaceutical technology
7.1 Introduction
7.2 Theoretical background
7.3 Application of CFD in pharmaceutical technology
7.4 Conclusion
JD